Lima PSI

Basic Information

• Brand Name: Lima PSI
• Primary DI: E314SHCLM100001
• Version / Model: SHC-LM10-00-01
• Catalog Number: SHC-LM10-00-01
• Company Name: Materialise NV
• Labeler DUNS: 373139427
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-01
• Public Version: 4
• Public Version Date: 2019-11-27
• Public Version Status: Update
• Public Device Record Key: 7b8c4398-8fb9-4d3e-b0ef-74b4c35b508e
• Distribution End Date: 2017-07-21

Device Description

Lima CT Full scapula bone model

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62215	Custom-made organ/bone anatomy model	A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E314SHCLM100001	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K153602	000